Systems Designer (IT/MES)
This is a remote working opportunity – while the role is classified as a remote working opportunity the chosen candidate MUST be available to be onsite in Dublin as required as occasional onsite work will be required.
Responsible for the delivery of new and updated integration functionalities for Manufacturing Information Systems for use in production. Responsible for oversight on alignment of Manufacturing Information Systems with Global Operating Specifications.
- Experience in the biotechnology and/or pharmaceutical industries is desirable but not a requirement.
- Demonstrate a keen interest working with multiple automation/IT systems.
- Responsible for the development, configuration and testing for integration components of Master Batch Records (MBRs) from initial to final design.
- Responsible for leading integration development design reviews including liaising with Automation, Operations, Process Development, Validation and Quality functions.
- Responsible for any applicable equipment integration design, configuration and testing to allow MBR interaction with shop floor equipment and lab equipment for in-process testing.
- Responsible for liaising with Plant Support, System Owner and Operations teams regarding documentation changes in an effective and timely manner.
- Responsible for support and updates to Recipe Control system.
- Responsible for the MBR design oversight, support and ongoing development of the MES system.
- Responsible for support and to assist in fast Manufacturing Execution System (MES) issue resolution where required and as directed by Operations leadership.
- Responsible for the development, review and update MES Standard Operating Procedures and Design Specifications.
Continuous improvement & Projects
- Support continuous area improvement, by proactively identifying and supporting implementation of improvement opportunities for MES integration removing paper from the execution and review process to reduce cycle times.
- Support implementation of process changes.
- Responsible to perform all activities in compliance with safety standards and site safety procedures.
- Strong interest in automation engineering.
- Initiative and ability to complete out on assigned tasks.
Educational / Experience Requirements:
- Level 8 Degree qualification (Science, Engineering, Technical).
- Very Strong Collaboration and Communication Skills.
- Minimum 5 years’ experience in industry, preferably in a pharmaceutical or biotechnology manufacturing environment.
- Knowledge of Quality Systems (e.g. CCMS, EDMQ, NC/CAPA).
- Knowledge of validation processes and understanding of validation protocol generation requirements.
- Knowledge of computer systems applicable to responsibilities (e.g. MES, ERP, SCADA, PLC, Historian).
- Practical knowledge in continuous improvement tools and methodologies.
- MES experience with focus on workflow, S95 & S88 standards and integration from the control layer to MES in pharma & bio-pharma industries.
- Previous experience in development and maintenance of PAS-X.
- Strong capabilities in S95 level 2 and level 3 systems and their integration.
- Experience of Process Control Systems (PCS), Kepware OPC Server, OSI Pi, RT Reports, OSI PI Asset Framework, Learning Management Systems.
- MES experience in implementing stable and scalable solutions for Continuous Data Retrieval from Level 2 and Level 3 systems.
- Strong SQL experience with exposure to both Oracle & SQL Server databases.
- Strong attention to details, including the ability to proof read documents and to accurately translate customers’ requirements into meaningful end-user instructions consistently.
- Excellent organizational and communication (verbal and written) skills at all levels of the organization.
Why Choose This Role & SL Controls
- An excellent compensation package which rewards high performers
- The opportunity to work clients who are global leaders in their field
- A supportive environment committed to employee development and wellness
- The opportunity to work with, help develop and improve upon industry leading technology solutions
- A collaborative and open culture where you are valued and can contribute to company initiatives and growth
About SL Controls
SL Controls are experts in the area of Equipment System Integration and System Support. We specialise in assisting our customers, including many of the world’s top multinational companies in the medical device and pharmaceutical sectors, achieve their Six Sigma and OEE targets.
Over the past 18 years we have grown our business from a Sligo based enterprise into an international business with additional offices in Galway, Limerick, Leinster and Florida USA.
We pride ourselves on our expertise in industrial IT integration and regulatory compliance in support of global end users, OEM’s and Technology providers.